Clinical Data Manager

Scope of the job

The Clinical Data Manager works under the hierarchal supervision of the Clinical Data Expert. The Clinical Data Manager reports on his/her activities and status of the study to the study team.

Main responsibilities / Major Activities

The Clinical Data Manager is responsible for all the steps required for the setup of the Data Management tools of a clinical trial and for the collection, review and validation of the clinical data in a timely manner; this to ensure adequacy, integrity and quality of the data that are used to answer the questions of our studies.

 Clinical Trial Management

Those tasks will be carried out by the Clinical Data Manager with the close coaching of a Clinical Data Expert:

Clinical trial protocol

  • Development of the Data Management sections of the clinical trial protocol
  • Defining the visit schedule
  • Assisting in final review of the clinical trial protocol for consistency

Case Report Forms

  • Development of the Case Report Forms in accordance with the protocol and the database
  • Definition of the Case Report Forms specifications
  • Development of the guidelines for Case Report Forms completion

Data handling

  • Coordination and control of data collection, data cleaning and data reporting activities
  • Application of QC to each stage in the data handling to ensure the data are reliable and processed in compliance with ICH-GCP requirements.
  • Communication with the participating investigators in order to resolve queries and collect missing data
  • Performing the reconciliation of SAEs with the clinical database

Other

  • Development and maintenance of the data management plans for the studies
  • Development of edit checks specifications
  • Preparation and attendance of the medical review meetings with the Clinical Research Physician
  • Preparation of bi-annual EORTC Group Members newsletters on the studies under her/his responsibility
  • Proper filing of all study related documents, in compliance with ICH-GCP requirements

Profile

  • Professional Bachelor’s or Master’s degree in a health-related or scientific discipline
  • Computer literate; programming skills as well as skills in the use and management of computer databases are strong assets
  • Knowledge of CDISC standards preferred, SDTM in particular
  • Experience in data monitoring and/or reviewing is an asset
  • Good organizational & administrative skills
  • Rigorous, attached to details
  • Excellent analytical skills
  • Team spirit
  • English very good (written & spoken), French & Dutch are assets

Application form


*Compulsary fields
Application should be sent in English

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